FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
71257–71280 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 2003
NITREX NITINOL GUIDEWIRE
K031864 · DQX
Ev3 Corporation
Cardiovascular · 8d
Cleared Jun 23, 2003
MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED...
K023333 · HIS
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 259d
Cleared Jun 23, 2003
PER, MODEL MEMO
K030218 · DXH
Medical Monitors Pty., Ltd.
Cardiovascular · 153d
Cleared Jun 23, 2003
BERKELEY V-10 VACUUM CURETTAGE SYSTEM
K030935 · HHI
Acmi Corporation
Obstetrics & Gynecology · 90d
Cleared Jun 23, 2003
EMBRYOGLUE
K031015 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 84d
Cleared Jun 23, 2003
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
K031038 · NBC
Bayer Healthcare, LLC
Chemistry · 83d
Cleared Jun 23, 2003
SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5
K031065 · MEG
Syringex Medical, Inc.
General Hospital · 81d
Cleared Jun 23, 2003
HEMOBAG, MODEL HBBSD2000
K031150 · DTN
Global Blood Resources, LLC
Cardiovascular · 74d
Cleared Jun 23, 2003
JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900
K031346 · OBJ
Jomed, Inc.
Cardiovascular · 55d
Cleared Jun 23, 2003
3TP SOFTWARE OPTION
K031350 · LNH
3tp, LLC
Radiology · 55d
Cleared Jun 23, 2003
VIVATHERM THEMPERATURE MEASUREMENT SYSTEM
K031556 · FLL
Vivant Medical, Inc.
General Hospital · 35d
Cleared Jun 23, 2003
DEPUY ACROMED VBR SYSTEM
K031635 · MQP
Depuyacromed
Orthopedic · 27d
Cleared Jun 20, 2003
NLITE SYSTEM, MODEL#: A00-1025/A00-1033
K024189 · GEX
Icn Photonics , Ltd.
General & Plastic Surgery · 183d
Cleared Jun 20, 2003
REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200
K024243 · MCW
Fox Hollow Technologies
Cardiovascular · 179d
Cleared Jun 20, 2003
PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300
K024259 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 179d
Cleared Jun 20, 2003
CTXA HIP EXTENDED REFERENCE DATA
K030330 · KGI
Mindways Software, Inc.
Radiology · 140d
Cleared Jun 20, 2003
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
K030944 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 86d
Cleared Jun 20, 2003
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE...
K030963 · HCG
Cordis Neurovascular, Inc.
Neurology · 85d
Cleared Jun 20, 2003
SENSE BODY COIL
K031095 · MOS
Philips Medical Systems (Cleveland),...
Radiology · 74d
Cleared Jun 20, 2003
SCANX 10
K031198 · MQB
Air Techniques, Inc.
Radiology · 65d
Cleared Jun 20, 2003
CONSULTIVA REPORT STATION, MODEL RS-1
K031248 · LLZ
Miramedica, Inc.
Radiology · 63d
Cleared Jun 20, 2003
INTEGRADWEB BY DYNAMIC IMAGING, INC.
K031311 · LLZ
Dynamic Imaging, Inc.
Radiology · 57d
Cleared Jun 20, 2003
HF MODULE WITH TRANSDUCERS
K031391 · IYO
Ophthalmic Technologies, Inc.
Radiology · 49d
Cleared Jun 20, 2003
TEMPORARY TITANIUM ANEURYSM CLIP
K031468 · HCH
Cardinalhealth
Neurology · 42d